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IRINOTECAN HYDROCHLORIDE TRIHYDRATE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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Package leaflet: Information for the user
Irinotecan 20 mg/ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1.
What Irinotecan 20 mg/ml concentrate for solution for infusion is and what it is
used for
2.
What you need to know before you use Irinotecan 20 mg/ml concentrate for
solution for infusion
3.
How to use Irinotecan 20 mg/ml concentrate for solution for infusion
4.
Possible side effects
5.
How to store Irinotecan 20 mg/ml concentrate for solution for infusion
6.
Contents of the pack and other information
1.

What Irinotecan 20 mg/ml concentrate for solution for infusion is and what
it is used for
Irinotecan 20 mg/ml concentrate for solution for infusion belongs to a group of
medicines called cytostatics (anti-cancer medicines).
Irinotecan 20 mg/ml concentrate for solution for infusion is used for the treatment of
advanced cancer of the colon and rectum in adults, either in a combination with other
medicines (for example: 5-fluorouracil/folinic acid, bevacizumab, cetuximab,
capecitabine) or alone (monotherapy).
2.

What you need to know before you use Irinotecan 20 mg/ml concentrate
for solution for infusion

Do not use Irinotecan 20 mg/ml concentrate for solution for infusion if you

are allergic to irinotecan hydrochloride trihydrate or any of the other ingredients
of this medicine (listed in section 6).

have any other bowel disease or a history of bowel obstruction

are breast feeding

have increased levels of bilirubin in the blood (more than 3 times the upper limit
of normal)

have severe bone marrow failure

are in poor general health (evaluated by an international standard)

are using the natural remedy St Johns' Wort (Hypericum perforatum)

Please consult the package leaflet of cetuximab, bevacizumab or capecitabine for
additional information about contra-indications for these medicines. Warnings and
precautions
This medicine is intended for adults only. Check with your doctor if this medicine has
been prescribed for use in a child.
Special care is also needed in elderly patients.
As Irinotecan 20 mg/ml concentrate for solution for infusion is an anti-cancer
medicine it will be administered to you in a special unit and under the supervision of a
doctor qualified in the use of anti-cancer medicines. The unit’s personnel will explain
to you what you need to take special care of during and after the treatment. This
leaflet may help you to remember that.
1) The first 24 hours after administration of Irinotecan 20 mg/ml concentrate for
solution for infusion
During administration of Irinotecan 20 mg/ml concentrate for solution for infusion (30
- 90 min) and shortly after administration you may experience some of the following
symptoms.

diarrhoea

sweating

abdominal pain

watering eyes

visual disturbance

excessive mouth watering
The medical term for these symptoms is acute cholinergic syndrome which can be
treated (with atropine). If you have any of these symptoms immediately tell your
doctor who will give you any treatment necessary.
2) From the day after treatment with Irinotecan 20 mg/ml concentrate for solution
for infusion until next treatment
During this period you may experience various symptoms, which may be serious and
require immediate treatment and close supervision.
Diarrhoea
If your diarrhoea starts more than 24 hours after administration of Irinotecan 20
mg/ml concentrate for solution for infusion (“delayed diarrhoea”) it may be serious. It
is often seen about 5 days after administration.
The diarrhoea should be treated immediately and kept under close supervision.
Immediately after the first liquid stools do the following:
1.
Take any anti-diarrheal therapy that the doctor has given you, exactly as he/she
has told you. The treatment may not be changed without consulting the doctor.
Recommended anti-diarrheal treatment is loperamide (4 mg for the first intake
and then 2 mg every 2 hours, also during the night). This should be continued
for at least 12 hours after the last liquid stools. The recommended dosage of
loperamide may not be taken for more than 48 hours.
2.
Drink large amounts of water and rehydration fluids immediately (i.e. water,
soda water, fizzy drinks, soup or oral rehydration therapy).
3.
Immediately inform your doctor who is supervising the treatment, and tell
him/her about the diarrhoea. If you are not able to reach the doctor, contact the

unit at the hospital supervising the Irinotecan 20 mg/ml concentrate for solution
for infusion treatment. It is very important that they are aware of the diarrhoea.
You must immediately tell the doctor, or the unit supervising the treatment if

you have nausea or vomiting as well as diarrhoea

you have any fever as well as diarrhoea

you still have diarrhoea 48 hours after starting the diarrhoea treatment
Note! Do not take any treatment for diarrhoea other than that given to you by your
doctor and the fluids described above. Follow the doctor’s instructions. The antidiarrheal treatment should not be used to prevent a further episode of diarrhoea, even
though you have experienced delayed diarrhoea at previous cycles.
Fever
If the body temperature increases over 38°C it may be a sign of infection, especially if
you also have diarrhoea. If you have any fever (over 38°C) contact your doctor or the
unit immediately so that they can give you any treatment necessary.
Nausea and vomiting
If you have nausea and/or vomiting, contact your doctor or the unit immediately.
Decreased number of white blood cells (Neutropenia)
Irinotecan 20 mg/ml concentrate for solution for infusion may cause a decrease in the
number of some of your white blood cells, which play an important role in fighting
infections. This is called neutropenia.
Neutropenia is often seen during treatment with Irinotecan 20 mg/ml concentrate for
solution for infusion and is reversible.
Your doctor should arrange for you to have regular blood tests to monitor these white
blood cells. Neutropenia is serious and should be treated immediately and carefully
monitored.
Breathing difficulties
If you have any breathing difficulties contact your doctor immediately.
Impaired liver function
Before treatment with Irinotecan 20 mg/ml concentrate for solution for infusion is
started and before every following treatment cycle the liver function should be
monitored (by blood tests).
If you have one or more of the symptoms mentioned, after you have returned home
from the hospital, you should immediately contact the doctor or the unit supervising
the Irinotecan 20 mg/ml concentrate for solution for infusion treatment.
Impaired kidney function
As this medicine has not been tested in patients with kidney problems, please check
with your doctor if you have any kidney problems.

Heart problems

If you have heart failure, an increased risk of developing heart failure or if you
previously had chemotherapy, talk to your doctor as Irinotecan 20 mg/ml concentrate
for solution for infusion may cause heart failure. Your heart function will be evaluated
before and during treatment with Irinotecan 20 mg/ml concentrate for solution for
infusion and measures will be taken to try to minimize all modifiable risk factors (for
example smoking, hypertension, and hyperlipideamia).
Vaccinations
Tell your doctor if you have recently received a vaccine or are scheduled to receive a
vaccine.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This is also valid for
herbal medicines, strong vitamins and minerals.
Some medicines may alter the effects of Irinotecan 20 mg/ml concentrate for solution
for infusion e.g. ketoconazole (for the treatment of fungal infections), rifampicin (for
the treatment of tuberculosis) and some medicines for the treatment of epilepsy
(carbamazepine, phenobarbital and phenytoin), warfarin (an anticoagulant used to thin
the blood) or other anticoagulants, atazanavir (used to treat HIV), ciclosporin or
tacromilus (used to dampen down your body’s immune system) and vaccines.
The herbal medicine St John's Wort (Hypericum perforatum) may not be used
concurrent with Irinotecan 20 mg/ml concentrate for solution for infusion and not
between treatments, as it may decrease the effects of Irinotecan 20 mg/ml concentrate
for solution for infusion.
If you require an operation, please tell your doctor or anaesthetist that you are using
this medicine, as it may alter the effects of some medicines used during surgery.
If you use Irinotecan 20 mg/ml concentrate for solution for infusion in
combination with medicines containing cetuximab, bevacuzimab or capecitabine
read the package leaflet of these medicines before use.
Pregnancy,breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine. Irinotecan 20
mg/ml concentrate for solution for infusion should not be used during pregnancy,
unless clearly necessary. Women of childbearing age should avoid becoming
pregnant.
Contraceptive measures must be taken by both male and female patients during and
for at least one and three months respectively after cessation of therapy. Still, if you
are pregnantor breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine..
It is unknown if Irinotecan 20 mg/ml concentrate for solution for infusion is excreted
in breast milk. Therefore breast-feeding should be discontinued for the duration of
Irinotecan 20 mg/ml concentrate for solution for infusion therapy.

Driving and using machines

In some cases Irinotecan 20 mg/ml concentrate for solution for infusion may cause
side effects which affect the ability to drive and use tools and machines. Contact your
doctor or pharmacist if you are unsure.
During the first 24 hours after administration of Irinotecan 20 mg/ml concentrate for
solution for infusion you may feel dizzy or have visual disturbances. If this happens to
you do not drive or use any tools or machines.
Irinotecan 20 mg/ml concentrate for solution for infusion contains sorbitol
.If you suffer from an intolerance to some sugars, tell your doctor before you are
given this medicinal product.
Irinotecan 20 mg/ml concentrate for solution for infusion contains less than 1 mmol
sodium (23 mg) per ml, i.e. essentially ‘sodium- free’.
3.

How to use Irinotecan 20 mg/ml concentrate for solution for infusion

For adults only.
Irinotecan 20 mg/ml concentrate for solution for infusion will be given as an infusion
into your veins over a period of 30 to 90 minutes.
The amount of infusion you are given will depend on your age, size and general
medical condition. It will also depend on any other treatment you may have received
for your cancer. Your doctor will calculate your body surface area in square meters
(m²).

If you have previously been treated with 5-fluorouracil you will normally be
treated with Irinotecan 20 mg/ml concentrate for solution for infusion alone
starting with a dose of 350 mg/m² every 3 weeks.

If you have not had previous chemotherapy you will normally receive 180
mg/m² Irinotecan 20 mg/ml concentrate for solution for infusion every two
weeks. This will be followed by folinic acid and 5-fluorouracil.

If you are treated with Irinotecan 20 mg/ml concentrate for solution for infusion
in combination with cetuximab, you will usually receive the same dose of
Irinotecan as administered in the last cycles of the prior irinotecan-containing
regimen.
If you receive Irinotecan 20 mg/ml concentrate for solution for infusion in
combination with cetuximab, Irinotecan 20 mg/ml concentrate for solution for
infusion must be administered at least 1 hour after the end of the cetuximab infusion.
If you use Irinotecan 20 mg/ml concentrate for solution for infusion in combination
with cetuximab, consult the package leaflet of cetuximab.
If you use Irinotecan 20 mg/ml concentrate for solution for infusion in combination
with bevacuzimab, consult the package leaflet of bevacuzimab.
If you use Irinotecan 20 mg/ml concentrate for solution for infusion in combination
with capecitabine, consult the package leaflet of capecitabine.
Please follow the advice of your doctor regarding your current treatment.
The length of your whole treatment period will depend on your progress and how well
you feel. Your doctor will tell you how long your treatment may last.
These dosages may be adjusted by your doctor depending on your condition and any
side-effects you may have.

If you think you have been administered more Irinotecan 20 mg/ml concentrate for
solution for infusion than you should, contact your doctor.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them. Your doctor will discuss these side effects with you and explain the risks and
benefits of your treatment. Some of these side effects can be serious. If you notice any
of the following serious side effects tell your doctor immediately as you may need
urgent medical attention (see also information in section “Take special care with
Irinotecan 20 mg/ml concentrate for solution for infusion”).
Very common: affects more than 1 user in 10

Anaemia (decreased number of red blood cells) which can cause a pale skin or
can cause weakness or breathlessness.

Neutropenia (decreased number of some white blood cells), which increases the
risks for infection.

In combination therapy, thrombocytopenia (decreased number of blood
platelets) which causes bruises and tendency to bleed and abnormal bleeding.

In monotherapy, fever and infection.

In monotherapy: fever in the absence of infection and without the concomitant
severe decrease in number of some white blood cells (neutropenia).

Delayed severe diarrhoea.

In monotherapy, severe nausea and vomiting.

Hair loss (the hair grows again after end of treatment).

In combination therapy, transient and mild to moderate increase in serum levels
of liver enzymes (SGPT, SGOT, alkaline phosphatase) or bilirubin.

In combination therapy with capecitabine all grade adverse drug reactions:
thrombosis/embolism.
Common: affects 1 to 10 users in 100

Severe transient acute cholinergic syndrome: the main symptoms are defined as
early diarrhoea and various other symptoms such as abdominal pain; red, sore,
itching or weeping eyes (conjunctivitis); running nose (rhinitis); low blood
pressure; widening of the blood vessels; sweating, chills; a feeling of general
discomfort and illness; dizziness; visual disturbances, pupil contraction;
watering eyes and increased salivation, occurring during or within the first 24
hours after the infusion of Irinotecan 20 mg/ml concentrate for solution for
infusion.

In monotherapy, thrombocytopenia (decreased number of blood platelets) which
causes bruises, tendency to bleed and abnormal bleeding.

In combination therapy, fever and infections.

In combination therapy: fever in the absence of infection and without the
concomitant severe decrease in number of some white blood cells (neutropenia).

Infections associated with a severe decrease in the number of some white blood
cells (neutropenia) resulting in death in 3 cases.

Fever associated with a severe decrease in the number of some white blood cells
(febrile neutropenia)











Loss of water (dehydration), commonly associated with diarrhoea and /or
vomiting.
Constipation.
In combination therapy, severe nausea and vomiting.
Feeling weak (asthenia).
In monotherapy, transient and mild to moderate increase in serum levels of liver
enzymes (transaminases, alkaline phosphatase) and bilirubin.
In combination therapy, transient severe increase in serum levels of bilirubin.
Transient and mild to moderate increases in levels of creatinine in the blood.
In combination therapy with capecitabine all grade adverse drug reactions:
hypersensitivity reaction, cardiac ischemia/infarction and grade 3 and grade 4
adverse drug reactions: febrile neutropenia.
In combination therapy with capecitabine and bevacuzimab: grade 3 and grade 4
adverse drug reactions: neutropenia, thrombosis/embolism, hypertension and
cardiac ischemia/infarction.

Uncommon: affects 1 to 10 users in 1,000

Mild allergic reactions including red itchy skin, urticaria, conjunctivitis, rhinitis.

Mild skin reactions; mild reactions at the infusion site.

Early effects such as breathing difficulties (dyspnoea).

Lung disease presenting as shortness of breath, dry cough and inspiratory
crackles (interstitial pulmonary disease).

Partial or complete blockage of the bowel (intestinal obstruction, ileus),
gastrointestinal bleeding.

Bowel inflammation, causing abdominal pain and/or diarrhoea (a condition
known as pseudomembraneous colitis).

Renal insufficiency, low blood pressure or cardio-circulatory failure in patients
who experienced episodes of dehydration associated with diarrhoea and/or
vomiting, or sepsis.
Rare: affects 1 to 10 users in 10,000

Severe allergic reactions including swelling of the of the hands, feet, ankles,
face, lips, mouth or throat which may cause difficulty in swallowing or extreme
difficulty breathing (anaphylactic/anaphylactoid reactions). If this happens you
should tell your doctor immediately.

Early effects such as muscular contraction or cramps and numbness
(paraesthesia).

Inflammation of the large bowel causing abdominal pain (colitis including the
appendix, ischemic and ulcerative colitis).

Intestinal perforation.

Loss of appetite (anorexia); abdominal pain; inflammation of the mucous
membranes.

Symptomatic or asymptomatic inflammation of the pancreas.

Increased blood pressure during and following administration.

Decreased levels of potassium and sodium in the blood, mostly related to
diarrhoea and vomiting.

Very rare: affects less than 1 user in 10,000





Transient speech disorders.
Increase in levels of some digestive enzymes which break down sugars
(amylase) and fats (lipase).
One case of peripheral thrombocytopenia with antiplatelet antibodies.

If you use Irinotecan 20 mg/ml concentrate for solution for infusion in combination
with medicines containing cetuximab, bevacuzimab or capecitabine, some of the side
effects you may experience can also be related to this combination, such as acneform
rash. Therefore please also read the package leaflet of cetuximab, bevacuzimab or
capecitabine.
If you get any side effects, talk to your doctor. This includes any side effects not listed
in this leaflet.
5.

How to store Irinotecan 20 mg/ml concentrate for solution for infusion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The content of the vial should be used immediately after the first breakage of vial.
Chemical and physical in-use stability has been demonstrated for 12 hours at 25 °C
and 24 hours at 2 to 8 °C. From a microbiological point of view, the product should
be used immediately. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would normally not be longer than
24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated
aseptic conditions.
If any precipitate is observed in the vials or after reconstitution, the product should be
discarded according to standard procedures for cytotoxic agents.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
6.

Contents of the pack and other information

What Irinotecan 20 mg/ml concentrate for solution for infusion contains

The active substance is irinotecan hydrochloride trihydrate.

1 ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate
equivalent to 17.33 mg of irinotecan.

One 2 ml vial contains 40 mg irinotecan hydrochloride trihydrate.

One 5 ml vial contains 100 mg irinotecan hydrochloride trihydrate.

The other ingredient(s) are sorbitol E420, lactic acid, sodium hydroxide,
hydrochloric acid and water for injections.
What Irinotecan 20 mg/ml concentrate for solution for infusion looks like and
contents of the pack
Irinotecan 20 mg/ml concentrate for solution for infusion is a clear, pale yellow
solution, free from visible particles.

Pack sizes:
1 x 2 ml
1 x 5 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Agila Specialties Polska Sp. z o.o.
10, Daniszewska Str
03-230 Warsaw
Poland
This leaflet was last revised in: 03/2015

The following information is intended for healthcare professionals only:
Instruction for use – Cytotoxic
Handling of Irinotecan 20 mg/ml concentrate for solution for infusion
As with all antineoplastic agents, caution should be exercised when handling
Irinotecan 20 mg/ml concentrate for solution for infusion. Dilution should be carried
out under aseptic conditions by trained personnel in a designated area. Precautions
should be taken to avoid contact with the skin and mucous membranes.
Protection instructions for preparation of Irinotecan 20 mg/ml concentrate for solution
for infusion
1.
Protective chamber should be used and protective gloves as well as protective
gown should be worn. If there is no protective chamber available mouth cover
and goggles should be used.
2.
Opened containers, like injection vials and infusion bottles and used cannulae,
syringes, catheters, tubes, and residuals of cytostatics should be considered as
hazardous waste and undergo disposal according to local guidelines for the
handling of HAZARDOUS WASTE.
3.
Follow the instructions below in case of spillage:

protective clothing should be worn

broken glass should be collected and placed in the container for
HAZARDOUS WASTE

contaminated surfaces should be flushed properly with copious amounts of
cold water

the flushed surfaces should then be wiped thoroughly and the materials
used for wiping should be disposed as HAZARDOUS WASTE

4.

5.

In the event of Irinotecan 20 mg/ml concentrate for solution for infusion contact
with the skin, the area should be rinsed with plenty of running water and then
washed with soap and water. In case of contact with mucous membranes, wash
the contacted area thoroughly with water. If you have any discomfort, contact a
doctor.
In case of contact of Irinotecan 20 mg/ml concentrate for solution for infusion
with eyes, wash them thoroughly with plenty of water. Contact an
ophthalmologist immediately.

Preparation of infusion solution
Irinotecan 20 mg/ml concentrate for solution for infusion concentrate for solution for
infusion is intended for intravenous infusion only after diluting prior to administration
in the recommended diluents, either 0.9 % sodium chloride solution for infusion or
5% glucose solution for infusion. Aseptically withdraw the required amount of
Irinotecan 20 mg/ml concentrate for solution for infusion concentrate for solution
from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle.
The infusion should be thoroughly mixed by manual rotation.
If any precipitate is observed in the vials or after reconstitution, the product should be
discarded according to standard procedures for cytotoxic agents.
Read the package leaflet for the shelf-life of the diluted product.
Irinotecan 20 mg/ml concentrate for solution for infusion should not be delivered as
an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than
90 minutes.
Disposal
All items used for preparation, administration or otherwise coming into contact with
Irinotecan 20 mg/ml concentrate for solution for infusion should undergo disposal
according to local guidelines for the handling of cytotoxic compounds.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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